Effects of Mechanical Insufflation-Exsufflation in Preventing Respiratory Failure After Extubation (MIEICU)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Miguel R. Goncalves, Hospital Sao Joao
ClinicalTrials.gov Identifier:
NCT01424202
First received: August 25, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

Weaning protocols that include the use of noninvasive ventilation (NIV), decreases the incidence of re-intubation and ICU length of stay. However, the role of NIV in post-extubation failure is still not clear. Impaired airway clearance is associated with NIV failure. Mechanical Insufflation-Exsufflation (MI-E) is an assisted coughing technique that has been proven to be very effective in patients under NIV.

In this study the investigators assess the efficacy of MI-E as part of a protocol for patients that develop respiratory failure after extubation.


Condition Intervention
Post-extubation Failure
Persistent Weaning Failure
Secretion Encumbrance
Weak Cough
Ventilatory Failure
Device: Mechanical Insufflation Exsufflation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Mechanical Insufflation-Exsufflation in Preventing Respiratory Failure After Extubation

Resource links provided by NLM:


Further study details as provided by Hospital Sao Joao:

Primary Outcome Measures:
  • re-intubation rates [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • NIV failure rates [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 92
Study Start Date: September 2008
Study Completion Date: October 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group B
Patients received (post-extubation) standard medical treatment (SMT), including NIV in case of specific indications plus daily sessions of mechanical in-exsufflation (MI-E).
Device: Mechanical Insufflation Exsufflation

After passing the SBT and randomized to group B, before extubation, all patients were submitted to a treatment of MI-E (3 sessions) through the endotracheal tube with pressures set at 40 cm H2O for insufflation and -40 cm H2O for exsufflation pressure. An insufflation/exsufflation time ratio of 3secs/2 secs and a pause of 3 sec between each cycle was used. Eight cycles were applied in every session with an abdominal thrust timed to the exsufflation cycle.

On top of the standard medical therapy, during the first 48 hours post extubation, each patient received 3 daily treatments by means of a light-weight, elastic oronasal mask. Treatments (3 sessions each) were divided between morning, afternoon and night, making a total of 9 daily sessions.

The daily treatment frequency and its outcomes were recorded in a diary by the nursing staff. All MI-E treatments were administered by a trained respiratory therapist, ICU physician or nurse.

No Intervention: Group A
Patients received (post-extubation) standard medical treatment (SMT), including NIV in case of specific indications.

Detailed Description:

Patients under mechanical ventilation (MV) for more than 48 hours with specific inclusion criteria, who successfully tolerated an spontaneous breathing trial (SBT) were randomly allocated before extubation, either for (A) conventional extubation protocol (control group) or (B) MI-E extubation protocol (study group). Re-intubation rates, ICU length of stay and NIV failure rates were analyzed.

Inclusion of MI-E in post-extubation failure may reduce re-intubation rates with consequent reduction in post-extubation ICU length of stay. This technique seems to be efficient in improving the efficacy of NIV in this patient population.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients older than 18 years and under mechanical ventilation, for more than 48 hours, for acute hypoxemic and/or hypercapnic respiratory failure from a specific etiology

Exclusion Criteria:

  • facial or cranial trauma, tracheostomy, active upper gastrointestinal bleeding, neurologic instability (inability to respond to direct simple orders), hemodynamic instability, lack of cooperation and confirmed diagnosis of neuromuscular disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01424202

Locations
Portugal
Intensive Care and Emergency Department;, Faculty of Medicine, University Hospital of S. João
Porto, Portugal, 4200-319
Sponsors and Collaborators
Hospital Sao Joao
  More Information

Publications:
Responsible Party: Miguel R. Goncalves, Professor, Hospital Sao Joao
ClinicalTrials.gov Identifier: NCT01424202     History of Changes
Other Study ID Numbers: MIEICU-08112010
Study First Received: August 25, 2011
Last Updated: August 25, 2011
Health Authority: Portugal: Ethics Committee for Clinical Research

Keywords provided by Hospital Sao Joao:
Post extubation failure
Mechanical Insufflation-Exsufflation
Noninvasive Ventilation
Weaning

Additional relevant MeSH terms:
Hypoventilation
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on September 14, 2014